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Not yet recruitingPHASE3INTERVENTIONAL

A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma

This study is looking into a new treatment called CRB-701 for a type of throat and tonsil cancer called oropharyngeal squamous cell carcinoma. This new drug is a 'targeted' chemotherapy, meaning it's designed to attack cancer cells more specifically. The study is for people whose cancer has returned or spread, and who have already tried other treatments like chemotherapy or immunotherapy. Researchers want to find out how well CRB-701 works compared to standard treatments currently used. They will also check its safety and how it affects patients' quality of life. The aim is to see if CRB-701 could be a better option for future cancer care.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
Corbus Pharmaceuticals Inc.
Enrolment target
260
Start
20 Sep 2026
Estimated completion
01 Mar 2029
Oropharyngeal Carcinoma (OPC)

What is this study about?

This study is designed to explore a new medicine called CRB-701 for people with a type of cancer that affects the throat and tonsils, known as oropharyngeal squamous cell carcinoma. This cancer can sometimes come back or spread after initial treatments.

CRB-701 is a special kind of chemotherapy called an 'antibody-drug conjugate'. Think of it like a guided missile: the antibody part is designed to find specific cancer cells, and then it delivers the chemotherapy drug directly to them. This approach aims to kill cancer cells while hopefully causing fewer side effects to healthy cells compared to traditional chemotherapy.

In this study, researchers want to compare CRB-701 with treatments that doctors would normally choose for this type of cancer (called 'standard of care'). They will look at how well CRB-701 shrinks or controls the cancer, its safety, and how it impacts people's day-to-day lives. The goal is to see if CRB-701 could offer a new and effective treatment option.

Key takeaways

  • This study is for a specific type of throat and tonsil cancer that has been previously treated.
  • It tests a new targeted chemotherapy called CRB-701 against standard treatments.
  • Participation involves regular clinic visits for infusions and scans.
  • The study aims to see if CRB-701 is more effective and safe.
  • You might receive the new drug or a standard treatment.
  • Your decision to join or leave the study is always respected.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with cancer in their throat or tonsils (oropharyngeal squamous cell carcinoma). Your cancer must have returned or spread, and it can't be treated with surgery or radiotherapy alone to cure it.

To join, you must have already received certain treatments for your cancer, such as platinum-based chemotherapy or immunotherapy. This means the study is for people who need further treatment after their initial therapies. Your general health and fitness, as assessed by your doctor, are also important.

There are also some reasons why you might not be able to join. For example, if you have ongoing serious side effects from previous treatments (like nerve damage in your hands or feet), or certain eye conditions. If you are pregnant or breastfeeding, you would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am 18 years old or older.
  2. I have been diagnosed with throat or tonsil cancer (oropharyngeal squamous cell carcinoma) that has returned or spread.
  3. I have already received chemotherapy or immunotherapy for my cancer.
  4. I am generally well and active enough for daily tasks.
  5. I do not have severe ongoing side effects from previous treatments like nerve damage in my hands/feet.
  6. I am not pregnant or breastfeeding.
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the clinic every three weeks. At these visits, you would receive the study medicine, either CRB-701 or one of the standard treatments, given through a drip (infusion). These treatments will continue until your cancer can no longer be measured, or if the treatment is no longer keeping your cancer under control.

Every six weeks, you would have scans (like CT or MRI) to see how the cancer is responding to the treatment. You would also be asked to fill out questionnaires regularly. These surveys help the research team understand how you are feeling and how the treatment might be affecting your daily life. The total time you spend in the study depends on how well the treatment works for you.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of accessing a new treatment, CRB-701, which might be more effective than standard care for your cancer. However, there's no guarantee that CRB-701 will work for you, and it could also cause side effects, some of which might be serious. The research team will closely monitor you for any problems. You will also contribute to medical knowledge, potentially helping future patients. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

  • The University of Arizona Cancer Center
    Verified postcode
    Tucson, United States
  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States
  • University of California Los Angeles Westwood Cancer Center
    Verified postcode
    Los Angeles, United States
  • Stanford Medicine - Cancer Center
    Verified postcode
    Palo Alto, United States
  • Moores Cancer Center
    Verified postcode
    San Diego, United States
  • UCSF Head and Neck Surgery Cancer Program
    Verified postcode
    San Francisco, United States
  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado
    Verified postcode
    Aurora, United States
  • Yale School of Medicine
    City only
    Newhaven, United States
  • Florida Cancer Specialists and Research Institute
    Verified postcode
    Orlando, United States
  • Moffitt Cancer Center Magnolia Campus
    Verified postcode
    Tampa, United States
  • University of Chicago
    Verified postcode
    Chicago, United States
  • Iowa Health Care Holden Comprehensive Cancer Center
    Verified postcode
    Iowa City, United States

Common questions

What type of cancer is this study for?

This study is for a type of throat and tonsil cancer called oropharyngeal squamous cell carcinoma, especially when it has returned or spread after previous treatments.

What is CRB-701?

CRB-701 is a new, targeted chemotherapy. It's designed to deliver treatment specifically to cancer cells, which might make it more effective and potentially reduce side effects.

Will I definitely receive the new drug CRB-701?

No, you might receive CRB-701 or one of the standard treatments normally used for your type of cancer. It's decided by chance, like flipping a coin, so researchers can compare the two fairly.

How long will I be on the study treatment?

You will receive treatment as long as it is helping to control your cancer and you are not experiencing unacceptable side effects. This means the duration varies for each person.

Can I leave the study once I've started?

Yes, you are free to withdraw from the study at any time, for any reason. Your decision will not affect your future medical care.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate CRB-701 Compared to Investigator's Choic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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